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This information can be used to develop food safety and quality programs that meet the requirements of modern Regulatory, Customer and Industry Standards:
When considering the development, documentation, and implementation of HACCP: Biological Hazards Management within food safety and quality management systems, the following information should be considered to ensure effective outcomes:
When considering the hazards associated with the process steps in the HACCP plans, the three traditional groupings of hazards to consider include biological, chemical, and physical hazards. As HACCP plans evolve and customer standards and regulatory requirements become more stringent, allergens, regulatory hazards, quality hazards, and engineering hazards are also commonly considered in HACCP Plans.
Biological hazards are situated at the high end of the scale of potential health risk, presenting the very real possibility of immediate and severe danger to the consumer, through the ability to cause food poisoning. The majority of food processing operations will be at risk from one or more biological hazards, either through the processing stages or from the raw materials entered into the process. A food safety system is designed to monitor and control these hazards. Biological Hazards can be classed as either macro-biological or Microbiological.
Macro-biological hazards including insects, flies, and the like, are objectionable when discovered, but rarely present a genuine risk themselves to food safety in its real context. Poisonous insects are an exception to this, and the presence of such microbiological hazards simply causes revulsion. Micro-biological hazards may, however, cause an indirect risk through the harborage of pathogenic microorganisms that may be introduced to food through contact. For example, an insect carrying Salmonella could pose a major threat if it gained access to ready-to-eat food but would become insignificant as a food safety threat if it gained access to an item to be cooked sufficiently before serving. The insect would be sterilized by the cooking process and would pose no great food safety risk, becoming a quality hazard instead. It is of obvious importance to ensure that food products are free of microbiological hazards, but it is always important to assess the risk level in a particular hazard.
Microbiological hazards are of far greater concern in food safety compared to their macro cousins. Pathogenic or food poisoning bacteria affect the human body either directly or indirectly. The degree to which contamination from microorganisms may occur is directly related to the conditions to which such microorganisms are subjected. Many microorganisms leave food unsuitable for use because the evidence of their presence indicates that the food has been improperly handled. Direct effects come as a result of an infection or the invasion of body tissues and are caused by the organism itself, including bacteria, viruses, and protozoa. The indirect effects are caused by the body’s reaction to the formation of poisons or toxins that are usually formed within the food that has been consumed. Toxin-producing microorganisms include bacteria and molds.
Microorganisms, as the name suggests, are very small and simply constructed living organisms, which in most cases need a microscope to be seen.
Microorganisms can be separated into five groups:
Bacteria are single-celled organisms that require significant magnification to be seen. They come in many different shapes, with round, rod, and spiral being the most common.
Three factors that are required for the growth of bacteria are:
Bacteria are mostly present in their vegetative form; however, some bacteria can produce spore forms, which are very difficult to kill with heat or chemicals. Not many foodborne disease bacteria will grow when temperatures reach freezing, but many may still survive. Most bacteria grow slowly at refrigerated temperatures, and growth rates increase with increased temperature; rapid growth occurs at room temperature. Several bacteria types survive higher temperatures, and a few can tolerate boiling for a short time.
Some foodborne disease bacteria form spores or protective shells when conditions are not suitable for growth. These bacteria can live for a long time in the spore stage in dry conditions, at adverse temperatures, and during exposure to some chemicals. When conditions are suitable again, the bacteria grow. Some foodborne disease bacteria do not grow very well when other competitive bacteria such as spoilage bacteria are present. Cooking food kills spoilage bacteria in the food and contributes to the growth of foodborne disease bacteria. Some bacteria produce a toxin or poison. Cooking the food may kill the bacteria but will not necessarily destroy the toxin.
Some important bacteria properties:
Molds are plant-like organisms that can be viewed without magnification. Some forms of molds are used as foods, including mushrooms and some cheese varieties, but generally, the presence of mold in or about foods indicates a discrepancy in the food handling system. Some molds can produce toxins called Mycotoxins or Aflatoxins, which can be responsible for food poisoning outbreaks. A prime example of a beneficial mold is Penicillium which is important not only to the production of some cheeses but also for the production of antibiotics such as penicillin.
Some important mold properties:
Viruses are extremely small and require enormous magnification to be viewed. Unlike bacteria, viruses do not generally grow and live in food. Food only serves as a vehicle from the source of contamination to the consumer. The primary contamination source is man, either directly or indirectly. A virus commonly attributed to foodborne disease outbreaks is Hepatitis. Contaminated shellfish, uncooked foods, and foods contaminated after cooking have contributed to a considerable number of Hepatitis outbreaks within global food markets.
Some important virus properties:
Parasites (including Protozoa) are simple single-celled organisms that are often found in water sources such as ponds, ditches, seawater, or groundwater. Parasites are often acquired from consuming raw or improperly cooked meats or seafood. Another less common parasite found in, or transmitted by food and water is protozoa. Infected persons transmit the organisms to food by not washing their hands after using the restroom. The larva of pathogenic flatworms, tapeworms, and flukes may infect humans via the consumption of infected meats from pork, beef, fish and shellfish, and wild game.
Some important parasite properties:
Algae are simple plants usually associated with growth in water. They are commonly found in water that is not treated or high in chlorine or sodium content.
Factors affecting the survival and growth of microbiological hazards include:
Microbiological pathogens or microorganisms that cause illness in humans can multiply most rapidly between the temperatures of 5 degrees Celsius or 40 degrees Fahrenheit and 60 degrees Celsius or 140 degrees Fahrenheit. The area including and in between these two temperatures is regarded as the danger zone for potentially hazardous foods. Bacteria may reproduce very slowly at freezing temperatures and lay dormant at temperatures of -18 degrees Celsius or 0 degrees Fahrenheit. Upon thawing, they may start to reproduce again, so freezing doesn’t necessarily destroy bacteria. Vegetative bacterial cells are destroyed after a few minutes at 100 degrees Celsius or 212 degrees Fahrenheit, but spores may require several more minutes at higher temperatures for deactivation.
The range of humidity that food is exposed to or kept in is of great importance regarding the water content at the food’s surface and related microbial growth. If food is dried compared to the humidity of the environment in which it is being stored, it will absorb moisture from the air and may become moist enough to support microbial growth
Micro-organisms of different varieties can survive and multiply in all different states of oxygen supply:
Some bacteria grow rapidly only in the presence of free oxygen; others require the absence of oxygen; some grow in both atmospheres and even others may have special atmospheric requirements. Cooking drives off oxygen; stirring, mixing, and beating foods introduce oxygen. Carbon Dioxide and Nitrogen gasses are often used in modified atmosphere packaging to retard the growth of some micro-organisms. Sulphur dioxide can be applied to both food and beverages as a liquefied gas, or in the form of sulphite, bisulphite, or metabisulphite salts to aid in the preservation of foods.
The pH of the environment is a measurement of the degree of acidity or alkalinity. The scale for pH ranges from 0 to 14. Acid-based foods will have a pH value of less than 7, while alkaline foods have pH values of more than 7. Most foods occupy the pH scale from 2.3 to 8.0. A pH of 7 is considered neutral. The majority of microorganisms thrive within 6.6 and 7.5 pH; Most bacteria of public health concern grow best at pH values between 4.6 and 7.5.
It is important to consider that mixing foods of different pH levels change the pH of the end mixture. Molds and yeasts will grow within wider ranges and overall, at much lower ranges than bacteria, pathogenic bacteria in particular.
The amount of water that micro-organisms require for growth and survival is defined in terms of water activity. Water activity is a term used to describe the water available in food for microorganisms to utilize. There must be adequate moisture for bacteria to grow. The amount of moisture needed is defined by the term water activity. Fresh meat with a high-water activity will support rapid bacterial growth, whereas a cured dried meat product beef jerky with a lower water activity will not. The water activity of a food substance can generally range from 0 to 1. Water has a water activity of 1.0, and pure silicone has a water activity value of 0. In general, bacteria need higher water activity levels to flourish than molds. Most food spoilage bacteria will not grow within products with low water activity, while spoilage molds can grow quite easily at these lower levels. Micro-organisms can survive at a much larger range of water activity levels than the range required for their growth.
The majority of micro-organisms use sugars, alcohols, and forms of amino acids as sources of energy. Fewer types of microorganisms utilize carbohydrates and fats as nourishment sources.
Inhibitory substances from bacteria themselves, or as a natural ingredient of food or added during food processing may slow down, stop or inhibit the growth of some bacteria or enhance the growth of others. Salt-cured meat products are a good example of this. Because of the salt concentration within the product, the growth of spoilage bacteria is inhibited. Growth inhibiting constituents are contained naturally in some foods. Such substances are found in cow’s milk, eggs, tea, fruits, and vegetables.
The natural coverings of some foods protect against the entry of microorganisms. These coverings only remain effective as long as the integrity of the covering is not compromised.
Examples of biological structures include:
If conditions are collectively within the correct boundaries, the numbers of bacteria present in food can double approximately every 20 minutes. Subsequently, food should be held within the temperature danger zone of between 5 degrees Celsius or 40 degrees Fahrenheit and 60 degrees Celsius or 140 degrees Fahrenheit for as short an amount of time as possible.
A minimum of a basic understanding of Food Microbiology Management is an elemental requirement for food industry personnel who participate in the development, implementation, and review of HACCP plans and finished product testing among other food safety and quality management system elements. This ensures that relevant microbiological hazards are effectively controlled and do not impact the safety or quality of finished food products.
Bacteria are everywhere in our environment! Most are harmless and are used to make foods, such as cheese. Others are spoilage organisms that sour and rot foods. A few bacteria become a threat to our health when they grow and reproduce; these are commonly known as microbiological pathogens. Sources of these bacteria include soil, water, air, dust, edible plants, plant products, animals, animal products, intestinal tracts of humans and animals, employees’ hands, and contaminated food utensils and equipment. A common misconception is that food is free of bacteria that cause food-borne diseases when it reaches the establishment or after processing.
Another common misconception is that healthy employees do not harbor harmful bacteria. Healthy humans commonly have their natural population of bacteria, and some are the variety that causes food-borne diseases. High percentages of the population are carriers of bacteria that cause food-borne illness. In this context, sick employees are carriers of greater numbers of organisms that cause food-borne illness.
Bacteria require nutrients, essentially foods to provide the basic elements for growth. These nutrients include carbon, hydrogen, oxygen, nitrogen, phosphorus, Sulphur, sodium, magnesium, iron, and manganese. Before bacterial growth can occur, other essential requirements must be favorable, such as temperature and the level of oxygen of the bacterial growth environment.
Bacterial growth refers to the increase in the number of organisms. This process is accomplished by Binary Fission, whereby the bacterial cell splits to form two cells. Bacterial growth can be very rapid. It may occur at a frequency of every 20 minutes in optimum conditions, but not until conditions are just right for the type of bacteria involved. There are four phases bacteria go through within their lifecycle; It is important to understand what takes place at each phase of the bacterial growth curve to be able to target effective control points for bacteria within a structured food safety and quality program.
Pathogens can be transferred from one food to another, either by direct contact or by food handlers, contact surfaces, or the air. Raw, unprocessed food should be effectively separated, either physically or by time, from ready-to-eat foods, with effective intermediate cleaning and where appropriate disinfection. Access to processing areas may need to be restricted or controlled. Where risks are particularly high, access to processing areas should be only via a changing facility. Personnel may need to be required to put on clean protective clothing including footwear and wash their hands before entering. Surfaces, utensils, equipment, fixtures, and fittings should be thoroughly cleaned and where necessary disinfected after raw food, particularly meat and poultry, has been handled or processed.
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific HACCP: Biological Hazards Management Development requirements in relation to their items.
Document: A document provides guidance and/or direction for performing work, making decisions, or rendering judgments that affect the safety or quality of the products or services that customers receive.
Documented policies, procedures, work instructions, and schedules form the basis of any food safety and quality management system. The following documentation formats may be considered to ensure ongoing compliance with specified requirements for HACCP: Biological Hazards Management:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific HACCP: Biological Hazards Management Documentation requirements in relation to their items.
You may wish to visit the HACCP: Biological Hazards Management Templates section of haccp.com for examples of HACCP: Biological Hazards Management documentation, record, and resource formats commonly applied within food safety and quality systems.
Implementation: Implementation is the application of documented food safety and quality system elements into the actual business operation.
The implementation of HACCP: Biological Hazards Management within any food business requires genuine commitment from senior management, staff, and visitors to ensure the nominated goals of implementation are achievable on an ongoing basis. It is a step that requires significant planning and consideration of general and specific food business circumstances to ensure the outcomes of HACCP: Biological Hazards Management do not negatively impact the safety and quality of the food items dispatched from the business.
Implementation of HACCP: Biological Hazards Management must include a clear definition of responsibilities and authorities for all levels of participation by senior management, staff, and visitors to the site.
When implementing HACCP: Biological Hazards Management within food safety and quality system, you may wish to consider the following requirements before completion:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific HACCP: Biological Hazards Management Implementation requirements in relation to their items.
Monitoring: Monitoring is the act of reviewing and confirming measurable parameters of a defined process or product status.
Monitoring requirements within food industry sectors are generally identified against limits of acceptability defined within HACCP plans, implementation procedures, and work instructions. Monitoring usually includes some element of record-keeping, which may be maintained manually or through digital systems. It is important to consider that advancements in technology have spawned many systems and processes which are self-monitored and or self-adjusted when variances are identified. Regardless of the system used, the goal of any monitoring activity is to provide sufficient evidence that any limit of acceptability has been met.
Traditional HACCP: Biological Hazards Management monitoring requirements include manual recording and the application of corrective actions when the results of monitoring are found to be outside acceptable limits. Corrective Actions should also generally be strongly linked to the monitoring process where applied to ensure full traceability of the applied actions.
Common monitoring activities and record formats may apply to HACCP: Biological Hazards Management:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific HACCP: Biological Hazards Management Monitoring requirements in relation to their items.
You may wish to visit the HACCP: Biological Hazards Management Templates section of haccp.com for examples of HACCP: Biological Hazards Management documentation, record, and resource formats commonly applied within food safety and quality systems.
Corrective Action: Corrective action is mandatory action to be taken when a deviation to the Quality System occurs, particularly in relation to a Critical Control Point.
Preventative Action: At any step in the process where a hazard has been identified, preventative action must be put into place to prevent re-occurrence.
Corrective Action and Preventative Action are implemented to ensure that any identified non-conformance issues are documented, investigated, and rectified within appropriate time frames. Corrective action is any action applied to regain control over a product, process, policy, or procedure that has been identified as being non-conforming or outside nominated limits of acceptability. Preventative action is any action applied to prevent any identified non-conformance from reoccurring.
The outcomes of corrective and preventative actions should result in regained process control after effective application. Specified corrective actions are commonly linked to the HACCP Plans and the food business certification process.
Below are Corrective Action and Preventative Action examples which may be associated with HACCP: Biological Hazards Management related non-conformance:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific HACCP: Biological Hazards Management Corrective Action requirements in relation to their items.
You may wish to visit the Corrective Action and Preventative Action section of haccp.com for examples of best practice applications for this food safety and quality system element.
Verification: The act of reviewing, inspecting, testing, checking, auditing, or otherwise establishing and documenting whether items, processes, services, or documents conform to specified requirements.
Verification is the detailed review of all food safety and quality system elements to confirm that they are effectively developed, documented, implemented, monitored, and reviewed. All food safety and quality system elements, including documented policies, procedures, training, HACCP plans and their operational applications must be verified on an ongoing scheduled basis. The verification process commonly includes a defined schedule for which verification activities are required, how often they are conducted, who is responsible, and detailed documented procedures for each nominated verification activity.
The general goal of an established verification process is to ensure any systemic non-conformance issues are identified and rectified within an appropriate time frame. When non-conformance issues are identified through the verification process, Corrective Actions and Preventative Actions should be implemented to ensure they do not impact the effectiveness of the food safety and quality system.
The following examples of verification activities may apply to HACCP: Biological Hazards Management:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific HACCP: Biological Hazards Management Verification requirements in relation to their items.
You may wish to visit the Verification Activities section of haccp.com for examples of best practice applications for this food safety and quality system element.
Validation: The process of gathering evidence to provide a scientific basis for the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment.
Validation is the provision of evidence to support the limits of control or acceptability for food safety or quality parameters nominated within systemic elements. Limits of control or acceptability are commonly included within documented food safety and quality systems elements such as procedures, HACCP plans, and specifications.
Common sources of validation include regulatory and legislative standards, finished product specifications and customer requirements, industry codes of practice and guidelines, verified and validated research, historical product, and process control outcomes, and analytical testing.
The general goal of an established validation process is to ensure any systemic non-conformance issues are identified and rectified within an appropriate time frame. When non-conformance issues are identified through the verification process, Corrective Actions and Preventative Actions should be implemented to ensure they do not impact the effectiveness of the food safety and quality system.
Validation activities are commonly defined within the verification schedules and procedures of established food safety and quality management systems.
The following examples may apply to validation of the limits of control or acceptability for HACCP: Biological Hazards Management:
You may wish to visit the Validation Activities section of haccp.com for examples of best practice applications for this food safety and quality system element.
Skills and Knowledge: Skills and knowledge are attributes of human interactions commonly linked to competency within any specified job-related task.
Training and Training and competency requirements for HACCP: Biological Hazards Management must be ongoing, including regularly scheduled reviews to ensure the effectiveness of training and competency outcomes.
Team members who have defined responsibilities regarding HACCP: Biological Hazards Management should have knowledge including:
Team members who have defined responsibilities regarding HACCP: Biological Hazards Management should have skills including:
Team members who have defined responsibilities regarding HACCP: Biological Hazards Management should have access to resources including:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific HACCP: Biological Hazards Management Training, Competency, and Resources requirements in relation to their items.
You may wish to visit the Training, Competency, and Resources section of haccp.com for examples of best practice applications for this food safety and quality system element.
haccp.com was created to support food businesses and food industry professionals in achieving and maintaining the stringent requirements of food industry compliance.